510(k) Report

Devices descending from K131286

5 later devices reach Primatrix Dermal Repair Scaffold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc.201644
+2K250397Helios Dermal ScaffoldHelios Biomedical, Inc.20250—
+2K201577MatriDermMedskin Solutions Dr. Suwelack AG20212—
+3K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+3K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—